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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.13, B.14 (Ames-Test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
bacteria, other: sat TA 98, 100, 102, 1535, 1537
Metabolic activation system:
Aroclor 1254 induzierter S9-Mix aus Rattenleber "ENGLISH" Aroclor 1254 induced S9 mix of rat liver
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 1581 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 1581 µg/plate)
Additional information on results:
Observations:
Ausfällung:

Bis 5000 µg/Platte wurde keine Ausfällung beobachtet.
Plattenincorporationstest :

Bis einschließlich 500 µg/Platte wurden keine
bakterientoxische Effekte beobachtet. Ab 1581 µg/Platte
wurden bakterientoxische Effekte beobachtet.

Nur TA 1537 zeigte sowohl mit als auch ohne S9-Mix im
Vergleich zur Negativkontrolle keine dosisbezogene,
biologisch relevante Zunahme von mutanten Zellen.

Der Test zeigt das die Substanz mutagenes Potential besitzt.

"ENGLISH"

Precipitation:

No precipitation was observed up to 5000 µg/plate.

Plate incorporation test:

No bacterial toxic effects were observed up to and including
500 µg/plate. Bacterial toxic effects were observed as from
1581 µg/plate.

Only TA 1537 did not exhibit any dose-related, biologically
relevant increase in mutant cells in comparison with the
negative control both with and without S9-mix. The test
shows that the substance possesses a mutagenic potential.
Remarks on result:
other: other: main test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive with metabolic activation
positive without metabolic activation